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U.S. Department of Health and Human Services

Post-Approval Studies (PAS)

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The FDA has the authority to require sponsors to perform a post-approval study (or studies) at the time of approval of a premarket approval (PMA), humanitarian device exemption (HDE), or product development protocol (PDP) application. Post-approval studies can provide patients, health care professionals, the device industry, the FDA and other stakeholders information on the continued safety and effectiveness (or continued probable benefit, in the case of an HDE) of approved medical devices. This database allows you to search Post-Approval Study information by applicant or device information.

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Atrial Fibrillation Registry

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Study Status Completed
Application Number P030031 S011/ PAS002
Date Current Protocol Accepted 01/05/2018
Study Name Atrial Fibrillation Registry
General Study Protocol Parameters
Study Design Prospective Cohort Study
Data Source New Data Collection
Comparison Group Objective Performance Criterion
Analysis Type Analytical
Study Population Transit. Adolescent B (as adults) : 18-21 yrs, Adult: >21
Detailed Study Protocol Parameters
Study Design Description The study is a prospective, multicenter, non-randomized clinical evaluation of PAF patients treated with the radio frequency ablation with Thermocool catheters.
Study Population Description Study Population: Adult patients with paroxysmal atrial fibrillation (PAF).
Sample Size A minimum of 381 patients, 109 in the MEP group and 272 in the LEP group, enrolled at 40 sites. Since the endpoint is 7-day primary AE rate, it is anticipated that the attrition for this endpoint is minimum. In P030031/S085, it is indicated that a total of 407 subjects received RF ablation procedure with 125 in the MEP group and 282 in the LEP group. Of the 282 subjects in the LEP group, 76 remaining subjects who have not reached 5-year follow-up won’t be followed through 5 years.
Data Collection The primary safety endpoints include adverse events that occur within 7 days of an ablation procedure.
Follow-up Visits and Length of Follow-up Study participants will be followed for 5-years.
Interim or Final Data Summary
Interim Safety Information No safety data is available for this study.
Actual Number of Patients Enrolled A total of 437 subjects with the 394 evaluable subjects, which met the required minimum of 381 evaluable subjects, were enrolled by October 01, 2013. The Safety Cohort (SC) included 408 subjects, which included enrolled subjects who received study catheter insertions. The Effectiveness Cohort (EC) included 394 evaluable subjects, with 120 in the more experienced physician (MEP) Group and 274 in the less experienced physician (LEP) Group.
Actual Number of Sites Enrolled A total of 21 sites.
Patient Follow-up Rate The 5-year overall follow-up rates in the SC and EC cohorts are 88.35% and 89.05%, respectively. The 5-year follow up rates for the SC are 89.60% and 88.05%, respectively, in the MEP and LEP groups, and for the EC, and 90.83% and 88.07%, respectively.
Final Safety Findings The study met the primary safety endpoint (i.e., primary adverse events (PAE) within 7 days of operation) for both MEP and LEP groups, with the upper bounds of the one-sided 95% confidence interval for the MEP and LEP being 10.5% and 9.3%, respectively, which are lower than the pre-determined performance goal of 16%. The percentage of PAE, 3.2%, of the MEP is lower than the 6.4% of the LEP as expected. With regards to the secondary long-term safety endpoints, first, by physician experience, the LEP group has a higher percentage of SAEs (39%) than that (32%) of the MEP group. Second, by time interval, the trends of the SAE occurrences (beyond 7 days of index operation) are slightly different between the MEP and LEP groups.
Final Effect Findings The overall success rates of entrance block for all targeted PVs were comparable between the MEP (95.8%, 115/120) and LEP (94.9%, 260/274) groups. With regards to the long-term effectiveness endpoint (without multiple lesions), the overall cumulative AF occurrence rate (78.3%) over the 5-year period in the MEP group was numerically higher than that (70.4%) in the LEP group, but the difference was not statistically significant. With respect to the long-term effectiveness endpoint with multiple lesions, the percentage for the overall cumulative AF occurrence (84.3%) over the 5-year period in the MEP group was numerically (but not statistically significantly) higher than that (67.3%) in the LEP group. In addition, the 1-, 2-, 3-, 4-year AF occurrence rates were consistently higher in the MEP than the those in the LEP with statistical significance.

Study Strengths & Weaknesses ¿ Study strength: This is a prospective, multi-center, long-term study with high 5-year follow-up rates and sufficient sample size for testing the primary endpoint.

¿ Study weakness: The AF recurrence data were collected based on subjective self- reporting rather than using an objective method such as ECG and Holter monitor. The study did not control for potential confounders for the relationship between physician ablation experience and effectiveness endpoint (i.e., AF occurrence) in the case of multiple lesions.

Recommendations for Labeling Changes The labeling changes should include new information stemmed from this PAS, such as the safety data with Tables and and the effectiveness data with Table from the final report.

Atrial Fibrillation Registry Schedule

Report Schedule
Date Due
FDA Receipt
Applicant's Reporting Status
6 mth report 02/12/2010 02/12/2010 On Time
1 year report 08/13/2010 08/13/2010 On Time
18 mth report 02/14/2011 02/14/2011 On Time
2 year report 08/12/2011 08/12/2011 On Time
3 year report 08/13/2012 08/08/2012 On Time
4 year report 08/12/2013 08/13/2013 Overdue/Received
5 year report 08/12/2014 08/08/2014 On Time
6 year report 08/12/2015 08/05/2015 On Time
7 year report 08/05/2016 08/05/2016 On Time
8 year report 09/30/2017 09/29/2017 On Time
final report 04/06/2018 04/06/2018 On Time

Contact Us

Julie Unger
Project Manager, Post-Approval Studies Program
Food and Drug Administration
10903 New Hampshire Ave
WO66-4206v Silver Spring, MD

Phone: (301) 796-6134
Fax: (301) 847-8140

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